Aurobindo Pharma arm’s New Jersey unit gets warning letter from USFDA

AuroLife Pharma, a wholly-owned step-down subsidiary of the company, has received a warning letter from the United States Food and Drug Administration (USFDA) for its oral solid manufacturing facility situated at Dayton

New Delhi: Drug firm Aurobindo Pharma Thursday said its step-down subsidiary has received a warning letter from the US health regulator for its unit in New Jersey, US.

AuroLife Pharma, a wholly-owned step-down subsidiary of the company, has received a warning letter from the United States Food and Drug Administration (USFDA) for its oral solid manufacturing facility situated at Dayton, New Jersey, Aurobindo Pharma said in BSE filing.

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This follows the earlier letter dated June 4, 2020, issuing an OAI (Official Action Indicated) status for this facility. Aurobindo Pharma said it believes the existing business from this facility will not be impacted. “The company will be engaging with the regulator and is fully committed in resolving this issue at the earliest,” it added. The drug firm, however, did not provide any details of the contents of the warning letter.